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Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions

NCT ID: NCT01532570

Last Updated: 2016-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-05-31

Brief Summary

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The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of TA-650 in patients with Behcet's disease ( BD ) with special lesions after the administration of TA-650 at a dosage of 5 mg/kg in weeks 0, 2, and 6, then every 8 weeks after week 14 up to week 46.

Detailed Description

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Conditions

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Behcet's Disease Behcet Syndrome Neuro-Behcet's Disease

Keywords

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Behcet's disease intestinal Behcet's disease neuro-Behcet's disease vascular Behcet's disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TA-650

Group Type EXPERIMENTAL

TA-650

Intervention Type DRUG

TA-650 will be intravenously infused at a dosage of 5 mg/kg slowly over a period of more than 2 hours at the first administration (weeks 0), 2, and 6, and then every 8 weeks up to week 46. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.

Interventions

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TA-650

TA-650 will be intravenously infused at a dosage of 5 mg/kg slowly over a period of more than 2 hours at the first administration (weeks 0), 2, and 6, and then every 8 weeks up to week 46. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who were diagnosed with the complete or incomplete type of Behcet's disease according to "The criteria for a diagnosis of Behcet's disease, Ministry of Health, Labour and Welfare in Japan (partially revised in 2010)"
* Patients who have special lesions despite having received conventional treatments for special lesions, or patients who cannot receive conventional treatments due to intolerability.
* Patients who have clinical symptoms associated with each special lesions.

Exclusion Criteria

* Patients with intestinal, neuro-, vascular Behcet's disease in whom a differential diagnosis of each Behcet's disease from other conditions．
* Patients who have received treatment with infliximab within 1 year before enrollment for another purpose than treating special lesions; or patients whose previous treatment with infliximab was discontinued due to adverse events.
* Patients who had participated in another clinical study and had received a study drug within 12 weeks before giving acquirement.
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yoshiaki Ishigatsubo, MD, Ph.D

Role: STUDY_DIRECTOR

Yokohama City University Graduate School of Medicine

Toshifumi Hibi, MD

Role: STUDY_DIRECTOR

Kitasato University Kitasato Institute Hospital

Shunsei Hirohata, MD

Role: STUDY_DIRECTOR

Kitasato University School of Medicine

Kazuoki Kondo, MD

Role: STUDY_DIRECTOR

Mitsubihsi Tanabe Pharma Corporation

Locations

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Investigational site

Chūbu, , Japan

Site Status

Investigational site

Hokkaido, , Japan

Site Status

Investigational site

Kanto, , Japan

Site Status

Investigational site

Kinki, , Japan

Site Status

Investigational site

Kyusyu, , Japan

Site Status

Investigational site

Tōhoku, , Japan

Site Status

Countries

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Japan

References

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Hibi T, Hirohata S, Kikuchi H, Tateishi U, Sato N, Ozaki K, Kondo K, Ishigatsubo Y. Infliximab therapy for intestinal, neurological, and vascular involvement in Behcet disease: Efficacy, safety, and pharmacokinetics in a multicenter, prospective, open-label, single-arm phase 3 study. Medicine (Baltimore). 2016 Jun;95(24):e3863. doi: 10.1097/MD.0000000000003863.

Reference Type RESULT
PMID: 27310969 (View on PubMed)

Other Identifiers

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TA-650-23

Identifier Type: -

Identifier Source: org_study_id